An allograft includes bone, tendon, skin, or other types of tissue that is transplanted from one person to another. Allografts are used in a variety of medical treatments, such as knee replacements, bone grafts, spinal fusions, eye surgery, and skin grafts for the severely burned. Allografts come from voluntarily donated human tissue obtained from donor-derived, living-related, or living-unrelated donors and can help patients regain mobility, restore function, enjoy a better quality of life, and even save lives in the case of cardiovascular tissue or skin.
Allograft processing centers are generally responsible for processing and cataloging allografts collected by organ procurement organizations (“OPOs”). The OPOs are, in turn, responsible for collecting and/or recovering voluntarily donated tissues and gathering any pertinent medical information about those tissues before transferring them to the processing center.
Once an allograft is received, the allograft processing center is then responsible for processing the allograft and readying it for safe and effective medical use. Such processing may involve several steps including inspection, testing, cleansing, and cataloging, all performed in government-certified (or equivalent) laboratories and subject to strict standards and regulations. To render the risk of disease transmission extremely remote, allograft tissue is processed to eliminate risk of infection transmission and tissue rejection. Grafts are sterilized and tissues are carefully preserved in an effort to retain the original structural and biological integrity of the graft. Quality assurance checks are incorporated into the preparation process, including aerobic and anaerobic cultures and any applicable additional testing.
Careful steps must be taken to ensure sterile integrity throughout the preparation process discussed above. In this regard, an allograft processing center often utilizes a high-purity water system that circulates sterile water throughout the processing center to each of the laboratories (e.g., clean rooms) used in the preparation process. Using this type of “loop” circulation system, sterile water that meets defined microbial limits is typically delivered via a distribution line to the processing field. Water is then returned as feed to the distillation and/or filtration system via a feedback loop for sterilization and reentry into the distribution line.
Loop water systems are effective at transporting water to the sterile environment, but they are expensive to operate. Every gallon of sterile injection water consumed comes at a cost, and, therefore, exercising control over water dispersal is paramount.